MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number 3788

Device Problems Low Battery (2584); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem No Code Available (3191)

Event Date 11/03/2014

Event Type  Injury  

Event Description

Follow-up identified surgical intervention was undertaken on (b)(6) 2014, explanting and replacing the ipg which resolved the issue.

Event Description

It was reported(netherlands) the ipg will not communicate with any external devices.In addition, an error message displays on the patient programmer indicating a low battery.Reportedly, troubleshooting was attempted with alternate external devices to no avail.Furthermore, the ipg is inoperable.Follow-up identified surgical intervention was undertaken, explanting and replacing the ipg which resolved the issue.The explant date is currently undetermined.Concomitant products: the implant date and model number is unknown for the below device: scs lead.

Manufacturer Narrative

Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

Manufacturer Narrative

Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

Manufacturer Narrative

Results: the complaint was confirmed.As returned, the ipg would not communicate due to a depleted battery.The battery was recovered and the ipg communicated, charged, and was tested to manufacturing specifications using the autotester.The ipg passed all tests.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

• Brand Name: EON MINI IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL NEUROMODULATION; 6901 preston road; plano TX 75024
• Manufacturer Contact: 6901 preston road; plano, TX 75024 ; 9723092520
• MDR Report Key: 4273658
• MDR Text Key: 5084223
• Report Number: 1627487-2014-01725
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2014,02/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/28/2013
• Device Model Number: 3788
• Device Lot Number: 3527822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/24/2014
• Date Manufacturer Received: 02/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other